Clinical Pharmacology Archives

Publication

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

CertaraMarch 20, 2025

Video

Behind the Science: A Conversation with Katrina Hui

CertaraMarch 5, 2025

Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…

CertaraMarch 4, 2025

Publication

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…

CertaraFebruary 25, 2025

Poster

Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease

CertaraFebruary 7, 2025

Blog

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…

CertaraJanuary 10, 2025

On-Demand Webinar

Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA)

In this on-demand webinar, "MBMA: Optimizing Drug Development with Aggregate Clinical Trial Data and Predictive…

CertaraJanuary 9, 2025

Publication

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs),…

CertaraJanuary 8, 2025

Poster

Population Pharmacokinetics (PopPK) of Revumenib in Patients with Relapsed/Refractory Acute Leukemias

CertaraDecember 12, 2024

Publication

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…

CertaraDecember 9, 2024

Clinical Pharmacology

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Behind the Science: A Conversation with Katrina Hui

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA)

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

Population Pharmacokinetics (PopPK) of Revumenib in Patients with Relapsed/Refractory Acute Leukemias

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

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